Pharmacokinetics of GLPG3067 in Male Subjects With Cystic Fibrosis.

Cystic Fibrosis Clinical Trial

Official title:

Evaluation of the Pharmacokinetics, Safety and Tolerability of a Single Dose of GLPG3067 Administered as Solid Formulation in Male Subjects With Cystic Fibrosis.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03589313
• Other study ID #: GLPG3067-CL-104
• Secondary ID: 2017-002294-19
• Status: Completed
• Phase: Phase 1
• Start date: February 12, 2018
• Est. completion date: March 26, 2018

Study information

• Verified date: July 2018
• Source: Galapagos NV
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This clinical study is a Phase I, open-label, single-center study designed to evaluate the pharmacokinetics profile of a single oral dose of GLPG3067 in adult male subjects with cystic fibrosis in fed state.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: March 26, 2018
• Est. primary completion date: March 26, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male subject =18 years of age on the day of signing the ICF.

• A confirmed clinical diagnosis of CF.

• Exocrine pancreatic insufficiency (documented in the subject's medical record).

• Stable concomitant medication regimen for pulmonary health for at least 2 weeks prior to study drug administration

Exclusion Criteria:

• History of clinically meaningful unstable or uncontrolled chronic disease that makes the subject unsuitable for inclusion in the study in the opinion of the investigator.

• Unstable pulmonary status or respiratory tract infection (including rhinosinusitis) requiring a change in therapy within 2 weeks prior to study drug administration.

• Need for supplemental oxygen during the day, and >2 L/minute while sleeping.

• History of solid organ or hematopoietic cell transplantation.

• History of hepatic cirrhosis with portal hypertension (e.g., signs/symptoms of splenomegaly, esophageal varices).

• Use of CFTR modulator therapy (e.g., lumacaftor or ivacaftor) within 2 weeks prior to study drug administration.

• Abnormal liver function test at screening, defined as aspartate aminotransferase (AST) and/or ALT and/or alkaline phosphatase and/or gamma-glutamyl transferase (GGT) =3x the upper limit of normal, and/or total bilirubin =1.5x the upper limit of normal.

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

Drug:
• GLPG3067 single dose
GLPG3067 film coated tablets provided at Day 1.

Locations

Country	Name	City	State
Belgium	University Hospital Leuven,Pediatric Pulmonology	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Galapagos NV

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum observed plasma concentration (cmax) of GLPG3067 single dose.	To evaluate the PK profile of GLPG3067 after a single oral dose of GLPG3067.	Between Day 1 pre-dose and Day 4.
Primary	Area under the plasma concentration-time curve from time zero until 24 hours post-dose ( (AUC0-24h) of GLPG3067 single dose.	To evaluate the PK profile of GLPG3067 after a single oral dose of GLPG3067.	Between Day 1 pre-dose and Day 4.
Primary	Area under the plasma concentration-time curve from time zero until 72 hours post-dose (AUC0-72h) of GLPG3067 single dose.	To evaluate the PK profile of GLPG3067 after a single oral dose of GLPG3067.	Between Day 1 pre-dose and Day 4.
Secondary	The number of subjects with adverse events.	To evaluate the safety and tolerability of a single oral dose of GLPG3067 in adult male subjects with CF.	From screening to 19 days after the last dose.